Do you produce medicines in Poland as an entrepreneur and want to sell them abroad? You should first obtain a Certificate of Pharmaceutical Product (CPP). Read below to find out more about the procedure.
How to proceed
This procedure can be completed:
- at an office
- by post
- electronically
What you should know and who can use this service
The Certificate of Pharmaceutical Product is an international document issued for a medicinal product for the purpose of its registration in a given country. The certificate confirms that the manufacturer of the medicinal product is authorised to manufacture the product which is to be placed on the international market.
The Certificate is issued on the basis of World Health Organization (WHO) guidelines by competent authorities in the member states of this organisation. In Poland, the certificate is issued by the Chief Pharmaceutical Inspectorate (GIF) for products manufactured in Poland.
If the marketing authorisation holder is a foreign company and the medicinal product is manufactured in Poland, then the marketing authorisation holder must authorise the manufacturer to apply for a CPP.
If the marketing authorisation holder is a Polish company and the manufacturing of the medicinal product takes place outside Poland, then the marketing authorisation holder must apply for a CPP to a competent authority in the country where the product is manufactured.
A list of authorities that issue such certificates in each country is available on the WHO website.
When you should complete this procedure
Before the pharmaceutical product is placed on the foreign market.
Where you can complete this procedure
GŁÓWNY INSPEKTORAT FARMACEUTYCZNY
ul. Senatorska
12,
00-082
Warszawa
What to do step by step
Apply for the Certificate of Pharmaceutical Product
Before filing the application, call 22 44 10 705 or send an e-mail to: cpp@gif.gov.pl to obtain an individual number for the Certificate of Pharmaceutical Product.
Detailed instructions on how to complete the application can be found on the WHO website.
Documents
Download:
You can submit a document as:
Oryginał
You can submit a document as:
Oryginał, Uwierzytelniona kopia
Download:
You can submit a document as:
Oryginał, Uwierzytelniona kopia
You can submit a document as:
Oryginał, Uwierzytelniona kopia
You can submit a document as:
Kopia
You can submit a document as:
Kopia
Time limit
Before the pharmaceutical product is placed on the foreign market.
The authority will check your application
If your application contains formal deficiencies (e. g. you have made a mistake in the application, or you have not attached the necessary documents), the office will call you to correct the deficiencies. You will have at least 7 days from the date of receiving the request to make corrections. If you fail to correct errors within the deadline, your application will not be considered.
You will receive the Certificate
Documents
You will receive a document as:
Oryginał
How much you will have to pay
Each issued Certificate is subject to a fee of PLN 17.
Additional fees may be required if the matter is handled by an attorney-in-fact (more on the power of attorney).
How long you will have to wait
You will receive the Certificate within 30 days from the date of submitting the application.
How can you appeal
If the office decides to refuse to issue the Certificate, you can request for your application to be reconsidered. Submit such request to the Chief Pharmaceutical Inspector (GIF) within 7 days from the date of delivery of the decision on refusal.